A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders

Susan A Stoner, Christian S Hendershot, Susan A Stoner, Christian S Hendershot

Abstract

Background: Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders. The availability of low-cost, sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes. Mobile health (mHealth) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions. We are evaluating a cell-phone-based intervention called AGATE that seeks to enhance adherence with regular text-messaging.

Methods/design: A randomized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting. Treatment-seeking heavy drinkers (N = 105) are currently being recruited and randomly assigned to the AGATE intervention or a control condition. Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions. Additionally, participants randomized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence.

Discussion: Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies.

Trial registration: NCT01349985.

References

    1. Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009;373:2223–2233.
    1. Bouchery EE, Harwood HJ, Sacks JJ, Simon CJ, Brewer RD. Economic costs of excessive alcohol consumption in the U.S., 2006. Am J Prev Med. 2011;41:516–524.
    1. Mann K, Hermann D. Individualised treatment in alcohol-dependent patients. Eur Arch Psychiatry Clin Neurosci. 2010;260(Suppl 2):S116–120.
    1. Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002;97:265–277.
    1. Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005;352:596–607.
    1. Kranzler HR, Stephenson JJ, Montejano L, Wang S, Gastfriend DR. Persistence with oral naltrexone for alcohol treatment: implications for health-care utilization. Addiction. 2008;103:1801–1808.
    1. Swift R, Oslin DW, Alexander M, Forman R. Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. J Stud Alcohol Drugs. 2011;72:1012–1018.
    1. Mark TL, Kranzler HR, Song X, Bransberger P, Poole VH, Crosse S. Physicians' opinions about medications to treat alcoholism. Addiction. 2003;98:617–626.
    1. Galvan FH, Bing EG, Fleishman JA, London AS, Caetano R, Burnam MA. et al.The prevalence of alcohol consumption and heavy drinking among people with HIV in the United States: results from the HIV Cost and Services Utilization Study. J Stud Alcohol. 2002;63:179–186.
    1. Hendershot CS, Stoner SA, Pantalone DW, Simoni JM. Alcohol use and antiretroviral adherence: review and meta-analysis. J Acquir Immune Defic Syndr. 2009;52:180–202.
    1. Samet JH, Cheng DM, Libman H, Nunes DP, Alperen JK, Saitz R. Alcohol consumption and HIV disease progression. J Acquir Immune Defic Syndr. 2007;46:194–199.
    1. Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM. et al.Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006;295:2003–2017.
    1. Kranzler HR, Armeli S, Tennen H, Blomqvist O, Oncken C, Petry N, Feinn R. Targeted naltrexone for early problem drinkers. J Clin Psychopharmacol. 2003;23:294–304.
    1. Baros AM, Latham PK, Moak DH, Voronin K, Anton RF. What role does measuring medication compliance play in evaluating the efficacy of naltrexone? Alcohol Clin Exp Res. 2007;31:596–603.
    1. Kim SG, Kim CM, Choi SW, Jae YM, Lee HG, Son BK, Kim JG, Choi YS, Kim HO, Kim SY, Oslin DW. A micro opioid receptor gene polymorphism (A118G) and naltrexone treatment response in adherent Korean alcohol-dependent patients. Psychopharmacol. 2009;201:611–618.
    1. Oslin DW, Lynch KG, Pettinati HM, Kampman KM, Gariti P, Gelfand L. et al.A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention. Alcohol Clin Exp Res. 2008;32:1299–1308.
    1. Rohsenow DJ, Colby SM, Monti PM, Swift RM, Martin RA, Mueller TI. et al.Predictors of compliance with naltrexone among alcoholics. Alcohol Clin Exp Res. 2000;24:1542–1549.
    1. Volpicelli JR, Rhines KC, Rhines JS, Volpicelli LA, Alterman AI, O'Brien CP. Naltrexone and alcohol dependence. Role of subject compliance. Arch Gen Psychiatry. 1997;54:737–742.
    1. Anton RF. Naltrexone for the management of alcohol dependence. N Engl J Med. 2008;359:715–721.
    1. Cramer J, Rosenheck R, Kirk G, Krol W, Krystal J. Medication compliance feedback and monitoring in a clinical trial: predictors and outcomes. Value Health. 2003;6:566–573.
    1. Pettinati HM, Volpicelli JR, Pierce JD, O'Brien CP. Improving naltrexone response: an intervention for medical practitioners to enhance medication compliance in alcohol dependent patients. J Addict Dis. 2000;19:71–83.
    1. Pettinati HM, Weiss RD, Miller WR, Donovan D, Ernst DB, Rounsaville BJ. In: COMBINE Monograph Series, Volume 2. Mattson ME, editor. US DHHS, Bethesda, MD; 2004. Medical Management Treatment Manual: A Clinical Research Guide for Medically Trained Clinicians Providing Pharmacotherapy as Part of the Treatment for Alcohol Dependence. Publication No. 04–5289.
    1. Dimeff LA, Paves AP, Skutch JM, Woodcock EA. In: The Oxford Handbook of Clinical Psychology. Barlow DH, editor. Oxford University Press, New York; 2010. Shifting paradigms in clinical psychology: how innovative technologies are shaping treatment delivery; pp. 618–648.
    1. Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012;14:e51.
    1. Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W. et al.Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376:1838–1845.
    1. Sobell LC, Sobell MB, Leo GI, Cancilla A. Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict. 1988;83:393–402.
    1. First MB, Spitzer RL, Gibbon M, Williams JB. Structured Clinical Interview for DSM-IVTR Axis I Disorders, Research Version, Patient Edition (SCID-I/P) Biometrics Research, New York State Psychiatric Institute, New York; 2002.
    1. Rosner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010;12:CD001867.
    1. Simoni JM, Huh D, Frick PA, Pearson CR, Andrasik MP, Dunbar PJ, Hooton TM. Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. J Acquir Immune Defic Syndr. 2009;52:465–473.
    1. Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41:1149–1160.
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–191.
    1. Johnson BA. Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Biochem Pharmacol. 2008;75:34–56.
    1. Johnson BA, Ait-Daoud N. Neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Psychopharmacology (Berl) 2000;149:327–344.
    1. Srisurapanont M, Jarusuraisin N. Naltrexone for the treatment of alcoholism: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2005;8:267–280.
    1. O'Malley SS, Croop RS, Wroblewski JM, Labriola DF, Volpicelli JR. Naltrexone in the treatment of alcohol dependence: a combined analysis of two trials. Psychiatr Ann. 1995;25:681–688.
    1. Chick J, Anton R, Checinski K, Croop R, Drummond DC, Farmer R. et al.A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse. Alcohol Alcohol. 2000;35:587–593.
    1. Zweben A, Pettinati HM, Weiss RD, Youngblood M, Cox CE, Mattson ME. et al.Relationship between medication adherence and treatment outcomes: the COMBINE study. Alcohol Clin Exp Res. 2008;32:1661–1669.
    1. Weiss RD. Adherence to pharmacotherapy in patients with alcohol and opioid dependence. Addiction. 2004;99:1382–1392.
    1. Bernhardt JM, Usdan S, Mays D, Arriola KJ, Martin RJ, Cremeens J, McGill T, Weitzel JA. Alcohol assessment using wireless handheld computers: a pilot study. Addict Behav. 2007;32:3065–3070.
    1. Collins RL, Morsheimer ET, Shiffman S, Paty JA, Gnys M, Papandonatos GD. Ecological momentary assessment in a behavioral drinking moderation training program. Exp Clin Psychopharmacol. 1998;6:306–315.

Source: PubMed

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